Warning; Device Description; Intended Use/Indications For Use; Contraindications - Boston Scientific Contour Mode D'emploi

Contour
™
Embolization Particles
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.

warnInG

Contents supplied STERILE using a Radiation process. Do not use if sterile barrier is
damaged. If damage is found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization may compromise the structural integrity of the device and/or lead to
device failure which, in turn, may result in patient injury, illness or death. Reuse,
reprocessing or resterilization may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not limited to, the
transmission of infectious disease(s) from one patient to another. Contamination of the
device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital, administrative
and/or local government policy.

DEVICE DESCrIPTIOn

The Contour Embolization Particles are irregularly-shaped polyvinyl alcohol embolization
devices. These devices are intended to provide vascular occlusion or reduction of
blood flow within target vessels upon selective placement through a variety of infusion
catheters.
The Contour Embolization Particles are packaged sterile, 1 cm
vial, in a peel-away pouch.
Each vial is intended for single use only. Do not resterilize. Discard any unused
material.
The Contour Embolization Particles size ranges are listed below and are available either
as a box of two vials or a box of five vials.
Contents
• Vials of Contour Embolization Particles
1000-1180 µm
Contour Embolization Particles Size Range - Minimum Catheter I.D. Required.

InTEnDED USE/InDICaTIOnS fOr USE

The Contour Embolization Particles are used for the embolization of peripheral
hypervascular tumors, including leiomyoma uteri and peripheral arteriovenous
malformations (AVMs).
Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

COnTraInDICaTIOnS

Contraindications Specific to All Peripheral Indications
1. Vascular anatomy or blood flow precludes stable, selective Contour Embolization
Particles or catheter placement
2. Presence of vasospasm
3. Presence of hemorrhage
4. Presence of severe atheromatous disease
5. Presence of feeding arteries smaller than distal branches from which they emerge
6. Presence of collateral vessel pathways potentially endangering normal territories
during embolization
(1 cc) dry volume per
3
7. Presence of arteries supplying the lesion not large enough to accept Contour
Embolization Particles
8. Vascular resistance peripheral to the feeding arteries precluding passage of
Contour Embolization Particles into the lesion
9. In large diameter arteriovenous shunts
10. In the pulmonary vasculature
11. Patient intolerance to occlusion procedures

COnTraInDICaTIOnS SPECIfIC TO UTErInE fIbrOID EMbOlIzaTIOn (UfE)

1. Pregnant women
2. Suspected pelvic inflammatory disease or any other active pelvic infection
3. Any malignancy of the pelvic region
4. Endometrial neoplasia or hyperplasia
3
Minimum Compatible
Size
45-150 µm
0.53 mm (0.021 in)
150-250 µm
(e.g., Renegade™ 18 Microcatheter,
250-355 µm
Renegade STC Microcatheter)
355-500 µm
0.69 mm (0.027 in)
500-710 µm
(e.g., Renegade HI-FLO™ Microcatheter)
710-1000 µm 1.12 mm (0.044 in)
(e.g., Imager™ II Catheter)
Catheter ID